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If a standard is an ASTM test method already has a precision and bias statement, what else needs to be done to validate the test method?

Last Updated On September 16, 2025

ISO 11607-1 and ISO 11607-2 require “all test methods used to show compliance with this part of ISO 11607 shall be validated and documented.” ASTM has developed test methods and some of these methods do have inter laboratory studies conducted providing confidence the method could be validated. All ASTM test methods should still be validated by the users. F3263 “Standard Guide for Packaging Test Method Validation” provides guidance on how to perform a test method validation.

As stated in the introduction to F3263, “This is due to the fact that there needs to be a great deal of flexibility in how these test methods are used. Not all circumstances and test methods require the same degree of scrutiny. Therefore, when assessing when, why, and how a test method should be validated, it is critical to keep this flexibility in mind and use the best tools available to answer the above questions appropriately for a given situation. A robust risk assessment process is arguably the best tool for determining the risk associated with a particular design element being tested. For example, there are clear differences in the risk associated with testing the adhesion of a label versus testing the integrity of a sterile barrier when viewed from the perspective of patient safety. If a label is missing, the product would be discarded, and a new one that is properly labeled chosen. However, if the sterile barrier has been compromised due to a seal breach or pinhole in the web of the material, this may go undetected, a contaminated device may be used, and the patient may become infected.”